N/A
Completed N=37
Cardiovascular Prevention for Persons With HIV
HIV · Cardiovascular Disease Risk
Source: ClinicalTrials.gov NCT00982189 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants Who Stated (by Self-report) That They Had Side Effects — 1; 0; 2; 1 participants
Summary
This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).
Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Stated (by Self-report) That They Had Side Effects |
1; 0; 2; 1 | — |
| PRIMARY Number of Participants Who Took >90% of Their Doses (by Pill Count) |
2; 7; 5; 6 | — |
| PRIMARY Change From Baseline to Month 4 in the Framingham Risk Score (FRS) |
-1.6; -0.7; -1.5; -0.3 | — |
| SECONDARY Changes in Blood Pressure |
-1.8; -3.3 | — |
| SECONDARY Changes in Blood Lipids |
-1.75; -0.62; 0.97 | — |
| SECONDARY Changes in Small Artery Elasticity |
0.02 | — |
| SECONDARY Changes hsCRP (C-reactive Protein) |
-1.00 | — |
| SECONDARY Changes IL-6 (Interleukin-6) |
-0.33 | — |
| SECONDARY Changes TNFa (Tumor Necrosis Factor Alpha) |
-0.14 | — |
Eligibility Criteria
Inclusion Criteria
- HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
- Age ≥40
- Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy
Exclusion Criteria
- Known cardiovascular disease or Framingham risk score (FRS) ≥20%
- Blood pressure ≥140/90
- LDL cholesterol ≥160 (with FRS 2x upper limit of normal
- Chronic kidney disease and a creatinine >2.0mg/dL
- Triglycerides >500mg/dL
Data sourced from ClinicalTrials.gov (NCT00982189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.